UK government responds to consultation on clinical trial legislation 6 Apr 2023

In order to strengthen the UK’s regulatory environment for clinical trials in an increasingly competitive global market, the government plans to prioritise safety and efficacy, while minimising regulatory burdens on trial sponsors.

The Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA) and Northern Ireland Department of Health announced proposals to reform current legislation, which is based on the EU Clinical Trials Directive, now that the UK has left the EU. These were consulted on in early 2022.

Following consideration of over 2,000 responses, the government has published its response and committed to four main steps: to ensure patient safety and promote diversity in trials; to create a proportionate and flexible regulatory environment; promote the UK as a destination for international trials, and provide a framework that is streamlined, agile and responsive to innovation.

Read the full government response here.

The changes outlined above align with other initiatives, including the review of clinical trials being led by Lord O’Shaughnessy (due to be published this Spring) and Sir Patrick Vallance’s review of a pro-innovation regulatory environment.

The Clinical and Contract Research Association (CCRA) took part in the consultation and will be holding a seminar on these topics as part of its ‘UK Clinical Research – A Professional Awareness Update’ series on 28 April 2023.